What are the challenges in managing compliance and the difference between compliance and quality management positions? You’ll learn more by listening to today’s guest.
In today’s episode, we spoke with Maryann Mitchell on the topic of Compliance Management. Maryann Mitchell is a Solutions Engineer at Greenlight Guru and is part of what we call our Guru Edge. She has more than 15 years of experience in Medical Devices and has worked in a variety of quality and regulatory roles.
Listen to the episode to learn what Maryann has to share about the cultural barriers between engineering and quality management, the challenges she experienced as a compliance manager, and what aspects of implementing an eQMS stood out.
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Some of the highlights of this episode include:
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What the compliance manager role was like for Maryann and what it meant to her
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The relationship with compliance across departments
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Auditing across sites
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Pains companies go through when looking for quality management systems
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Cultural barriers between engineering and quality control
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Compliance manager challenges
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How the quality management system is like a design project
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The contrast in quality manager vs. compliance matter
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Implementing an eQMS and the difference between that and a paper system
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The relationship between compliance and quality departments
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Advice for people filling multiple roles
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Advice for companies working toward compliance and developing a quality mindset.
Links:
Memorable quotes from Maryann Mitchell:
“Engineers love to iterate, they love to tinker, but you need to be able to document something, and that’s the importance of it so you can go back to it if you need to.”
“We built better processes going forward so we wouldn’t recreate this problem.’
“I love that you get to defend your quality system.”
“A quality system doesn’t work in a silo, and what I was seeing was departments working in silos.”
Transcript:
Etienne Nichols: Welcome back to the podcast today. With me today is Marianne Mitchell. She's a solutions engineer at Greenlight Guru. Marianne, how are you doing today?
Maryann Mitchell: I am fabulous, thank you.
Etienne Nichols: How are you doing? Well, Marianne's such. You're such a great sport, jumping on the podcast, like, last minute.
I keep getting this question from people, are we doing it today? Are we recording today? Like, yeah, we're recording today, if you're cool with it. So, I'm excited to get to talk to you today.
Tell us a little bit about your background. I know we already mentioned that a little bit earlier on, but one of the things that stood out to me in your background was compliance manager, and I'm curious what that role was like and what it meant to you.
Maryann Mitchell: Yeah, so I've been with Greenlight just a little over a year, but prior to joining, I spent over 15 years in the medical device industry.
All of my time was spent in some type of quality or regulatory function. But my last role,
I was the global compliance manager. And I was really lucky to be able to create that role. You know, that was. I saw that we needed it in the company that I was kind of doing document management, I was kind of doing change management and compliance on top of that, you know, managing audits, managing our eQMs.
So, I thought if we had a role specific to the compliance of the quality system, then I could be more focused on that. So that was what my job was. I was responsible for the quality system for a site in Salt Lake City, Utah, which is where I'm based, and then for a few sites around the country as well as around the world.
Etienne Nichols: Wow. So, when you. How many different countries, if I might ask?
Maryann Mitchell: Let's see. So, Netherlands, Germany. There were a few sites in Germany and then the U.S. okay, so I get.
Etienne Nichols: How did, how did the relationship with compliance go for across those departments? I mean, you're. You're looking at things almost through a different lens culturally, but just from the compliance manager standpoint, how did you interact with those other companies?
Maryann Mitchell: Yeah, for one, making sure that we right sized it. Because in Salt Lake, we had over a thousand employees, so we were able to get a little bit more detailed on those procedures, add, you know, a lot of roles and responsibilities. But then we had other sites that only had like 11 people, so we had to make sure. That if we're trying to have this procedure followed by multiple sites, we had to make sure that either it was right sized or it, if it would, it wasn't, then they needed to have their own process.
Etienne Nichols: Oh, wow, that's.
Yeah, that makes a lot of sense. So, did you, did you see that was kind of a consistent thing where they did have to have multiple of their own or did, did it cross pollinate pretty well?
Maryann Mitchell: Yeah, in some cases. And what we were really trying to do towards the end of my time there was to harmonize because we kept acquiring other businesses.
And rather than having multiple quality systems, we wanted to harmonize across the world. And you know, sometimes that works, sometimes that doesn't.
You know, for things like CAPAs and complaints, you know, let's make sure that we streamline those processes. But maybe you have a design control procedure that's, you know, one site is only doing like industrial products.
Well, the medical device procedure may be a little bit too heavy. So, we really had to sometimes take it site by site. And sometimes if it was a, like a manufacturing site that only spoke a different language, you know, we needed to make sure that we had things like work instructions in their native language as well.
Etienne Nichols: How does that work with like auditing? Does each site suppose they do have some specific SOPs and some that aren't? How does that work across those sites?
Maryann Mitchell: Yeah, I was very fortunate to be able to travel to some of the sites during some notified body audits and some FDA inspections as well.
But yeah, they would, they would. Right. Size it to that specific site. Sometimes they had their own certificate, sometimes it was shared between one to two different sites. So, depending on the scope of the certificate, the notified body or the FDA inspector would tailor it.
Etienne Nichols: Okay, that makes sense.
So now you work with a lot of different companies. What are some of the pains that you see companies going through as they're looking for those quality management systems?
Maryann Mitchell: Oh, so many pains.
I mean, document control, design control, not having the experience.
You know, they may be very small companies that have five to 10 employees and they're trying to figure it out. They may have this great idea for a medical device, but don't realize everything that comes with it.
So, things like design control, risk management, and then just the, all those outputs that you're producing. So, making sure that you've got your documents-controlled changes, controlled bills of materials controlled.
So, all the little things, but they end up being a lot more than people expect.
Etienne Nichols: Yeah, there's a word that you kept saying, and that was control. And I'm guessing that's really, that's maybe the biggest pain of all is, uh, as you start, you know, whatever device you're building, whatever, whatever medical device that you're working on, it's. Are you controlling all the different inputs and outputs and the documents related to those?
Are they.
Do you understand the revision and so forth? So, I'm sure with your years in compliance management, you probably could go a lot deeper than I could. So I'm curious, what were some of the, the, if, if we go back to your experience in the field, working directly with those, you know, across different sites, was there anything that you faced as far as how to actually get them to implement it in such a way that it's not, not just preparing for an audit type of implementation?
I think you know what I'm talking about. But what were some of the cultural barriers that you hit as far as, as far as implementing those things?
Maryann Mitchell: Yeah, this one isn't necessarily a cultural barrier, but as soon as you asked for an example, I remember walking into a conference room because I was called into the room and a group of people asked me like, we need your help.
We need to know what we sent this one company.
And I'm looking around, I'm like a group of engineers and they're like, well, we don't know what we sent them. I'm like, well, did you document the build?
You're like, we documented a few versions back, but not this one. And I'm looking around like, well, how am I supposed to know? Like, I was not involved in it.
Like, did you give it to my document control team so that they could document all the different parts that we sent? And they said no. So again, I was wondering like, what they wanted me to tell them.
Like, well, if we didn't write it down, you know, that's everybody's favorite line, it didn't happen. So, I, there's no way for me to know what we sent. And this was a very high-profile customer, and they weren't happy.
So, trying to instill that.
And engineers love to iterate, they love to tinker, but you need to be able to document something and that's the importance of it so that, that, you know, you can go back to that if you need to, you know, what did we send, what did we build, what did we validate to have all that controlled. So, I guess culturally the, you know, the differences between the mindset of engineering and the mindset of like a quality and regulatory person can be sometimes a difficult battle. Lots of education but that's also the fun part about being in quality and regulatory.
Etienne Nichols: Yeah. And that, I'm glad you asked that you gave that example because that's the definition culturally that I'm looking for. I, I don't know, sometimes I look past demographic and look more at psychographic.
You know, it's, it's what, what are you thinking versus what do you, I don't know, what do you look like or whatever. But yeah, engineering versus regulatory. That's a really interesting contrast. I guess that did you. I guess we didn't maintain control in that instance and there was no way to find out.
Maryann Mitchell: Yeah, we, we built better processes going forward so that we wouldn't recreate this problem. But it was a, a cultural change that had to happen in the organization to making sure that we went from a.
Because they were kind of like in startup mode but then realizing that you need to start documenting and being a little bit more formal in our processes.
Etienne Nichols: Yeah. And that maintain control. I mean it's, it's almost what we're really saying is maintain traceability a lot of times.
And I don't know, maybe control seems like a harsh word, but if you use that word, traceability, maybe that's, that's when I need to maybe implement back into my vocabulary a little bit more.
Because maintain traceability, that's one of the biggest I can remember in my background.
If you wanted to insult the VP of quality or and regulatory, you might say traceability was lost. He's like, we did not lose traceability.
And he, he would kill himself to make sure that we could, he could trace the product. So it was, it was an interesting learning experience for me about the value of traceability.
Because it really is valuable.
Maryann Mitchell: Absolutely.
Etienne Nichols: And not just valuable, it's required.
So, what are some other things that you saw as challenges that you, you know, maybe overcome or maybe struggle to overcome as a compliance manager?
Maryann Mitchell: Probably the over engineering of processes.
Sometimes you want control, but then you, you put yourself in corners. You over, just over commit to things. You know, we wanted a very controlled change process, for example, so we know everybody wanted to know what their step was along the way. And we ended up building a 19-step workflow.
So, it just became a huge bottleneck and all of a sudden it became my problem and my fault, my department's fault, that changes weren't going through faster.
So sometimes you can just, you can over engineer things and make them more complicated than they need to be.
Etienne Nichols: Yeah.
Yeah.
That's interesting too because a quality management system is really kind of Like a design project. I was talking to somebody else about that. What are your thoughts on that?
Maryann Mitchell: Yeah, Quality management system. I mean, if you look at the regulations, you look at the standard, they're. It's pretty basic. And sometimes that's good, and sometimes that's bad, because sometimes, you know, it says that you need a procedure, but that's all it says.
You know, maybe there'll be three or four bullet points on what the procedure needs to contain, but yeah, you. You get to create it; you get to build it. As long as you have those requirements met, then you get to defend it in an audit.
So that was some of the things I enjoyed doing, was being in an audit and really defending our quality system as part of being a compliance manager. You know, I get an auditor that would say, well, there's no watermark on this that says it's obsoleted.
I'm like, where does it say it needs to have a watermark? It says it needs to be identified as obsolete. And I can show you how it's identified that way.
So sometimes you win some, sometimes you don't with auditors. But I love that you get to defend your quality system.
Etienne Nichols: Yeah, that makes. That's.
So, I was never in the defense side. I was sometimes called into an audit room to support or whatever, but I wasn't the one talking directly to the auditor from a defending side. I don't think so. That's really interesting. That's. I'm sure that's. I don't know if it's a.
Exciting. I don't know. I don't know what. What happens to your blood pressure in that situation.
Maryann Mitchell: But I love audits. I thought they were fun and. And I was in so many audits that I kind of knew what question was coming. So, it was almost a race.
I'm like, okay, I know here comes this question. I'd already get the document ready to be able to show that was.
I'm an audit nerd.
Etienne Nichols: Yeah.
You mentioned you kind of designed the role yourself. As far as this compliance manager role, what's the contrast in compliance manager versus quality manager, or what are the unique things that you designed into that role?
Maryann Mitchell: I worked for a bigger organization, so we had the flexibility to kind of create different types of quality groups. So, we had like a supplier quality organization. We had product quality.
And then I was solely responsible for the compliance of the quality system in general, which, again, touched all of those.
But I got to basically create the framework and then have all the different departments feed into it.
Etienne Nichols: Okay, so what does that look like. When you're, I mean, why did you feel the need to build out that type of role? As far as, I don't know, all the quality management system parts, if it's touching other organizations? And I guess maybe the question behind the question is if I'm a, if I'm a small company and I'll get back.
I don't mean to ramble on with my question, but if I was a small company and I have a quality person in place, that they're basically going to have to be doing all those things, supplier quality, just quality in general, how that works, and then, and then this compliance piece.
But when you, when you talk about that compliance, building that out when the organization gets big enough, what.
Why did you feel like there was a need for that specific role?
Maryann Mitchell: The biggest thing was, and going back to that word that you used, you know, traceability. And, you know, a quality system doesn't work in a silo. And, and what I was seeing is departments working in silos.
So, the way that I brought the cohesiveness to, okay, you may be doing supplier quality, but this is how, you know, it needs to connect to the purchasing process and to design controls and making sure that all those different departments were not only communicating, but their processes were connected.
Etienne Nichols: Okay. And you had an EQMS at the time. Did you ever work with paper or. I'm just curious.
Maryann Mitchell: I did, yeah, in a past life. And then when I first got hired, I helped implement an eQMS.
Etienne Nichols: Okay. What. In your mind, what's the difference?
Maryann Mitchell: Let's just keep using that word. Traceability.
I like it.
I like to have those connection points because when I'm in an audit, I'm showing an auditor a document. Okay, where's the change to that document? Okay. I can easily pull up the change. I don't need to go into a filing cabinet to go find that change into another filing cabinet to, to find who's been trained to it.
If I am an engineer designing my process, I can have all of my drawings tied to my outputs. I can have my test protocols, test reports right there with my verifications.
So having it in at least one location, you know, bigger organizations may have multiple systems, but as much as possible, giving that ability to access your document, but then have the traceability to other processes.
Etienne Nichols: Okay. And so, if I, I don't know if I, I know we work for an eQMS, so we obviously, we've got that on our resume, I guess. But what if, what if I were to make the argument, well, what about SharePoint and Google?
What's the difference in using them versus an EQMS?
Maryann Mitchell: Probably the purpose-built portion.
We talk to companies every day that use Google, Microsoft, you know, network drives. I did that in a past life too. It works. You know, we know we didn't have eQMS way back when. You know, it was possible to bring out the binder during an audit and show it, but it just, it would take audits a lot longer. It would make processes harder. And as we grow and scale, not just, you know, as a company, but globally, you know, most companies have a global footprint.
You don't have to, I mean, I used to have to send documents to other states, other countries for people to sign them.
You know, now you can sign things electronically and it's all aligned to the medical device and regulations.
Etienne Nichols: Yeah, okay.
Maryann Mitchell: Regulations.
Etienne Nichols: Yeah, that makes sense. That makes sense. Okay, well, what's, what's one of your favorite things about,
I don't know, moving from paper to an eQMS. As far as the actual.
I, I'll, I'll give a story from my background and, and I'll let you think of one for a second if that's cool.
I remember we were kind of like a hybrid system at one company I worked with where we,
we use SharePoint Dropbox for some things, but we also ran and got paper and Docusign.
But we also had physical signatures for certain reports.
So, I remember one report I was routing, and I took it to the VP of Quality and he's like, all right, I'll get it signed tomorrow. I was like, okay, so I'll come back tomorrow.
Came back tomorrow and he had lost it. He could not find it on his desk and drove me crazy because I had already gone through DOT control, I had gone through regulatory, and now here it was at the VP of Product development is who it was.
And that happened twice. And I, I, after that happened the second time, I was pretty much a believer in let's, let's get this process into our online, whatever that is at the time. So, I don't know if you have anything that you experienced similar in a, in an, in a digital world.
You know, I don't know what the equivalent is, but. What are your thoughts?
Maryann Mitchell: Yeah, absolutely. I've been in those situations. I used to be a document control coordinator. So, I would create the actual change packets. So, packets of different documents that are changing, you know, physically redline them and hand them to, whether it's the engineering manager or the product line manager to sign and the next day it's gone.
So, now we have to recreate all of that change information.
So, it just, it takes so much time to figure out where it is. I used to have to manage spreadsheets that like, here's the change, here's who it's currently sitting with. Then I'd get it back and I would change the date on the spreadsheet. Now I'd give it to this person, put a new date.
So, a lot of just administrative work that gets alleviated by having an electronic system.
Sure.
Etienne Nichols: That's a really, that last statement you said, the administrative work.
I mean, I remember when I was managing a design controls or risk management or whatever spreadsheet, you want to look at it and you look at yourself and at some point, you think, man, I went to, I'm a mechanical engineer. I didn't want to just change cells all day long and check everything and make sure that it's right before I send it out. So, it winds up taking a lot of your time.
So that's, that's a really good point.
Okay, what are so from a compliance management system or compliant compliance manager perspective, what were some of the, how were the relationships with those, those other departments, that quality department, supplier quality department.
Were you guys pretty close? And how did, how did that, what did that look like?
Maryann Mitchell: Yeah, really try to, not just with other quality groups, but, you know, engineering, production, upper management really trying to build a good relationship because I always saw them as allies, sometimes they didn't see me as an ally, but I was always there for the benefit of the company.
So maybe it's not necessarily product quality, which sometimes upper management is more concerned with, but making sure that you make those good relationships so that you can work well with these individuals because they're, you know, working right alongside you. You need to have compliance and high-quality product.
Etienne Nichols: Yeah, yeah, that's absolutely true. So that word compliance, you know, sometimes it gets a bad rap. We talk about true quality and, you know, we want to have.
I don't, for lack of a better word, I use the word excellence in everything we do. I mean, the quality almost gets overused sometimes. But true quality in my mind is true excellence and, but the compliance is required within that. So, it's almost like your organization broke out like a multifaceted gym and had each person really perfecting each one of these different, different parts. Is there any advice you could give to someone who does kind of have.
Wears all of the hats? Any advice you could give to that person?
Maryann Mitchell: Probably trying to have a True quality mindset throughout the organization.
Because, you know, sometimes we'll say, oh, we're passing all of our audience audit audits, so we're in compliance. But are we doing things with the best intent? Are we building quality into our processes, into our culture, so that it's not just about passing audits, it's doing the best work, documenting things well and teaching everyone that it's the right thing to do.
Etienne Nichols: Yeah.
Maryann Mitchell: Because at the end of the day, we're making medical devices that are helping people.
So, if we don't have that quality mindset in our organization, it filters into our products and then that's the last thing we need, is a product out in the field that's going to hurt somebody.
Etienne Nichols: Yeah, absolutely.
So.
Well, very cool. Any last pieces of advice that you'd give to companies who are either working towards compliance or quality? True quality mindset. Any. Any last words?
Maryann Mitchell: Probably going back to that true quality and trying to understand the values of the organization. Going back to, you know, the mission of your product, the vision,
working with those quality groups. And if you don't understand.
I think we love to teach, so we want to make sure that you understand the why that. Why we're doing things.
Why do we document complaints? Why do we need to have CAPAs? Why do we need.
Most organizations aren't big fans of CAPAs, but it's because we want to improve our processes. We're not here to add more work. We're here to making sure that we have quality product not just today, but tomorrow as well.
Etienne Nichols: Yeah, that's really good. Well, awesome. Thank you, Marianne. I appreciate you talking to me about this role and some of the things that you've done in the past.
Maryann Mitchell: Thank you.
Etienne Nichols: Yeah, hope you have a good rest of your day. We'll see you all later.
Maryann Mitchell: Hi.
Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review, and subscribe on your favorite podcast platform. If you've got thoughts or questions, we'd love to hear from you.
Email us podcast@greenlight.guru.
Stay connected for more insights into the future of MedTech innovation. And if you're ready to take your product development to the next level. Visit us at www.greenlight.guru. until next time, keep innovating and improving the quality of life.
About the Global Medical Device Podcast:
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
